Colo-rectal CancerFIND-CRCNCT07046585
Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
An observational study of Colo-rectal Cancer, run by Natera, Inc. at 1 site in United States.
Trial summary
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 25,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 30 Sep 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants 40 years of age or older who are at average risk of colorectal cancer and scheduled for a screening colonoscopy as part of their standard of care.
Who may be able to join
- Signed informed consent.
- 40 years of age or older at the time of consent.
- Planning or intending to undergo a standard of care colonoscopy.
- Able to tolerate venipuncture for research draw(s).
- Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.
- Willing and able to comply with the study visit schedule and study requirements.
Who cannot join
- Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancers may be enrolled, provided the procedure was completed at least 12 months prior to consent for the study).
- Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
- Undergoing diagnostic colonoscopy for the investigation of symptoms.
- Up to date with colorectal cancer screening from any non-invasive test.
- Precancerous findings on most recent colonoscopy.
- Had a prior colorectal resection for any reason other than sigmoid diverticular disease.
- Known personal history of any of the following high-risk conditions:
- 7a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Natera, Inc
Austin, Texas, 78753
About this study
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.
Read the detailed description
Participants who meet study inclusion criteria will be invited to enroll in the study and will provide written consent prior to study procedures. Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw. No test results from the blood collection will be provided to participants or clinicians.
- Conditions
- Colo-rectal Cancer
- Keywords
- colorectal cancer, colon cancer, early cancer detection
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants at average risk for colorectal cancer | Participants 40 years of age or older at time of consent, planning or intending to undergo asymptomatic screening colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The primary outcomes of this study are sensitivity of the Natera CRC Screening Test for the detection of colorectal cancer (CRC) and specificity of the test for advanced neoplasia (AN), as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
Measured: 24 months
Secondary outcomes (1)
Secondary Outcomes
The secondary outcomes of this study are sensitivity and specificity of the Natera CRC Screening Test for the detection of Advanced Precancerous Lesions (APL) and specificity of the test for Negative findings, as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 May 2025
- Primary completion10 Jul 2027 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Natera, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046585
- Sponsor's protocol ID
- 25-080-ECP
- Acronym
- FIND-CRC
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
- ClinicalTrials.gov ID
- NCT07046585
- Acronym / sponsor ID
- FIND-CRC / 25-080-ECP
- Conditions
- Colo-rectal Cancer
- Keywords
- colorectal cancer, colon cancer, early cancer detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.
Detailed description
Participants who meet study inclusion criteria will be invited to enroll in the study and will provide written consent prior to study procedures. Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw. No test results from the blood collection will be provided to participants or clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants at average risk for colorectal cancer | – | –Participants 40 years of age or older at time of consent, planning or intending to undergo asymptomatic screening colonoscopy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants 40 years of age or older who are at average risk of colorectal cancer and scheduled for a screening colonoscopy as part of their standard of care.
Key inclusion criteria (6 listed)
- Signed informed consent.
- 40 years of age or older at the time of consent.
- Planning or intending to undergo a standard of care colonoscopy.
- Able to tolerate venipuncture for research draw(s).
- Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.
Key exclusion criteria (8 listed)
- Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancers may be enrolled, provided the procedure was completed at least 12 months prior to consent for the study).
- Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
- Undergoing diagnostic colonoscopy for the investigation of symptoms.
- Up to date with colorectal cancer screening from any non-invasive test.
- Precancerous findings on most recent colonoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome
Time frame: 24 months
The primary outcomes of this study are sensitivity of the Natera CRC Screening Test for the detection of colorectal cancer (CRC) and specificity of the test for advanced neoplasia (AN), as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
1 secondary outcome
Secondary Outcomes
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Natera, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FIND-CRC Study team (650-489-9050, findcrc_ctgov@natera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.